In Vitro Diagnostics EUAs

November 8, 2023 - The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023. The COVID-19 enforcement policy guidances within scope of the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.

The end of the COVID-19 PHE and certain COVID-19 enforcement policy guidances no longer being in effect do not impact the FDA's ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act. The FDA encourages manufacturers of devices issued EUAs related to COVID-19 to review the guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19), which outlines the FDA's recommendations and expectations to such manufacturers to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?

March 24, 2023 - The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for:

The FDA encourages stakeholders to review the two final guidances, view the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.

In vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases.

There are several types of SARS-CoV-2 and COVID-19 related IVDs:

Since the Secretary’s declaration under section 564 of the Federal Food, Drug, and Cosmetic Act related to in vitro diagnostic tests for COVID-19, on February 4, 2020, the FDA has granted EUAs for many COVID-19 tests, based on a determination that they met the statutory criteria for EUA. EUA-authorized tests can continue to be used as long as they are available and not expired and the EUA has not been revoked. This page provides information about these EUAs.

The FDA has been working with COVID-19 test developers seeking to pursue marketing authorization through the traditional premarket review pathways, which will allow these tests to continue to be used beyond the time allowed by emergency use authorization. See COVID-19 Tests Granted Traditional Marketing Authorization by the FDA for additional information on COVID-19 tests that have received traditional marketing authorizations, as well as information about the traditional premarket review and authorization process.

Tables of IVD Emergency Use Authorizations:

The web pages below include tables of SARS-CoV-2 and COVID-19 related IVDs with emergency use authorizations (EUAs).